Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Stimulator, Muscle, Powered
510(k) Number K955146
Device Name AXIOM-HVG
Applicant
Axiom Manufacturing
717 Lingo Dr. # 202
Richardson,  TX  75081
Applicant Contact CHARLES OSBORNE
Correspondent
Axiom Manufacturing
717 Lingo Dr. # 202
Richardson,  TX  75081
Correspondent Contact CHARLES OSBORNE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/13/1995
Decision Date 05/17/1996
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-